Kornimate/medical-research-clean huggingface dataset:
the study of apatinib plus cik as the third line therapy for patients with advanced gastric cancer

Conditions: Stomach Neoplasms

Summary: the purpose of this study is to evaluate the safety and efficacy of apatinib combined with cytokine-induced killer cell (cik) vs apatinib as the third line therapy for patients with advanced gastric cancer.

400 patients with stage ⅳ gastric cancer,who had received surgery and chemotherapy,will be randomly divided into group a（receive apatinib and cik treatment ) or group b（just receive apatinib),and the randomize ratio will be 1:1. patients in group a will receive 3 cycles of cik treatment (every 1 year) and apatinib (continuous).patients in group b will receive only apatinib (continuous) .

Eligibility criteria:
inclusion criteria: * patients who can accept curative operations 18-70 years old * histologically confirmed with gastric cancer at stage ⅳ * patients who can accept oral drugs; * eastern cooperative oncology group (ecog) performance status was 0 - 1. exclusion criteria: * hemoglobin\<8.0 g/dl,white blood cell \<3 x 10\^9/l;platelet count \<75 x 10\^9/l; alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times * known or suspected allergy to the investigational agent or any agent given in association with this trial * pregnant or lactating patients * known history of human immunodeficiency virus (hiv), hepatitis c virus (hcv) or treponemapallidun (tp) infection * patients who are suffering from serious autoimmune disease * patients who had used long time or are using immunosuppressant * patients who had active infection * patients who are suffering from serious organ dysfunction * patients who are suffering from other cancer * other situations that the researchers considered unsuitable for this study.

Keywords: cik gastric cancer apatinib
immune cells in diabetic chronic foot ulcers

Conditions: Diabetic Foot; Immune Defect

Summary: the goal of this observational study is to learn about the role of immune cells in patients with diabetes and chronic foot ulcers. researchers will compare blood and tissue samples of patients with diabetes and a foot ulcer that is healing or healed compared to those diabetic patients where the foot ulcers is not healing (chronic ulcer).

diabetic foot ulcer (dfu) requires frequent hospital visits, anti-biotic therapies, and surgical procedures. not only this approach has debilitating consequences for patients and enormous costs for the health care system, but it is often not sufficient to prevent lower limb amputation. the immunological response in wound healing is mainly orchestrated by recruited monocytes and skin macrophages. the current hypothesis is that hyperglycaemia sustains an activated macrophages' phenotype that inhibits wound healing. however, well controlled diabetes is not associated with better healing, and not all the diabetic patients develop chronic foot ulcers. in this project, the investigators aim to characterize the immunological response of patients with dfu to discover new therapeutic targets for the treatment of chronic wounds. the investigator suggest that an altered metabolic local environment can re-program monocytes/macrophages towards dysfunctional phenotypes unable to accomplish the healing process. here, by using a longitudinal study cohort combined with clinical information, transcriptomic and proteomic analysis at single cell level, researchers will characterize the landscape of monocytes/macrophage populations involved in healing, and non-healing, foot ulcers. functional validation will be performed in human skin organoids. my group's unique access to patient material combined with cutting-edge methodologies provides an exceptional platform to identify genes and pathways involved in chronic dfu.

Eligibility criteria:
inclusion criteria: * diabetes with diabetic foot ulcer exclusion criteria: * impaired cognitive function * on-going immune suppressive treatment * diagnosed active cancer * cancer treatment * known chronic inflammatory disease
prostate cancer - localized adenocarcinoma proton therapy

Conditions: Prostate Adenocarcinoma

Summary: a phase ii randomized trial of hypofractionated proton therapy in patients with a localized prostate adenocarcinoma

for proton therapy with prostate adenocarcinoma patients. arm 1: proton therapy 3cge x 20days = total 60 cge for 4 weeks. arm 2: proton therapy 4.7cge x 10days = total 47 cge for 2 weeks.

Eligibility criteria:
inclusion criteria: * biopsy proven prostate adenocarcinoma stage: t1-t2cn0m0 * ecog performance status:0-1 * signed study specific informed consent prior to study entry. exclusion criteria: * postoperative residual or recurrent tumor * evidence of distant metastasis previous irradiation for the tumor in the same location * adjuvant anti-androgenic hormonal therapy high risk group (nccn guide line)
sunrise study - stroke rehabilitation in suriname

Conditions: Stroke

Summary: this study aims to determine the effect of a supervised home-based physical fitness program on the aerobic capacity, quality of gait and health related quality of life in people with chronic ischemic stroke. secondly, feasibility of the program for implementing a long term lifestyle change will be investigated.


Eligibility criteria:
inclusion criteria: * ability to give informed consent * ability to understand measurement procedures defined as mmse \>24 * last stroke \>6 months ago * mild to moderate stroke deficit defined by fugl meyer test score of 27 to 90 for upper and lower extremities * fac ≥3 * medical clearance to participate in a moderate exercise program * living at home and having a minimum of 5 stairs at home exclusion criteria: * serious cardiac condition * other serious end organ damage * other neurological deficits leading to disability * uncontrolled blood pressure (systolic pressure \>140, diastolic pressure \>90)
epirubicin and cyclophosphamide followed by docetaxel and trastuzumab in treating women with her2-positive stage iii or stage iv breast cancer

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy, such as epirubicin, cyclophosphamide, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. some block the ability of tumor cells to grow and spread. others find tumor cells and help kill them or carry tumor-killing substances to them. giving chemotherapy and a monoclonal antibody before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. purpose: this phase ii trial is studying how well giving epirubicin and cyclophosphamide followed by docetaxel and trastuzumab works in treating women with her2-positive stage iiib, stage iiic, or stage iv primary breast cancer.

objectives: primary * determine the pathological complete response in women with her2-positive stage iiib-iv breast cancer treated with neoadjuvant epirubicin hydrochloride and cyclophosphamide followed by docetaxel and trastuzumab (herceptin®). secondary * determine the clinical response in patients treated with this regimen. * determine the recurrence-free survival of patients treated with this regimen. * determine the overall survival of patients treated with this regimen. outline: this is a multicenter study. patients receive epirubicin hydrochloride and cyclophosphamide in weeks 1-3. treatment with epirubicin hydrochloride and cyclophosphamide repeats every 3 weeks for 4 courses. patients then receive docetaxel in week 13 and trastuzumab (herceptin®) in weeks 13-15. treatment with docetaxel and trastuzumab repeats every 3 weeks for 4 courses. patients then undergo appropriate surgery. after surgery, patients with hormone receptor-positive disease receive trastuzumab once weekly and either tamoxifen with or without a luteinizing hormone-releasing hormone agonist or an aromatase inhibitor. treatment continues for 40 weeks. projected accrual: a total of 40 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of primary breast cancer * stage iiib, iiic, or iv disease * no inflammatory disease * her2 over-expressing tumor as assessed by immunohistochemistry and/or fluorescent in situ hybridization * hormone receptor status known patient characteristics: * female * menopausal status not specified * performance status 0-1 * wbc ≤ 10,000/mm³ * absolute neutrophil count ≥ 2,000/mm³ * platelet count ≥ 100,000/mm³ * hemoglobin ≥ 9.5 g/dl * sgot/sgpt ≤ 60 iu/l * bilirubin ≤ 1.5 mg/dl * creatinine ≤ 1.5 mg/dl * lvef ≥ 55% * no signs of pneumonitis prior concurrent therapy: * no prior surgery except for biopsy * no prior or concurrent chemotherapy and/or hormonal therapy * no prior or concurrent biological therapy * no prior or concurrent radiotherapy except postoperative radiotherapy

Keywords: stage iiib breast cancer stage iiic breast cancer stage iv breast cancer
evaluation of oxygenation parameters in patients undergoing rhinoplasty under general anesthesia

Conditions: Anesthesia; Functional

Summary: the investigators are planning to compare the oxygenation values (pao2/fio2, lactate etc.) in patients who underwent tci and inhalation anesthesia in rhinoplasty operation.

total intravenous anesthesia (tiva) is a common anesthesia method used today as an alternative to inhalation anesthesia. loss of consciousness is two important components of general anesthesia, in order to give the patient safe analgesia and not to remember any adverse events related to the operation. while the depth of anesthesia can be controlled by monitoring the minimum alveolar concentration (mak) in the ventilator devices in the operating room we use modernly, there was no more objective method than measuring the plasma level of drugs in intravenous anesthesia. the schemes created by the anesthetists according to plasma drug levels were used when administering total intravenous anesthesia. target controlled anesthesia (tci) devices, on the other hand, are pumps that have been used more frequently recently and that can deliver the required blood concentration of a drug in bolus and infusion form according to pharmacokinetics models calculated with personal data. in tci anesthesia, intravenous infusion of anesthetics provides a more stable drug concentration in the plasma and at the site of action compared to repeated bolus techniques. thus, it is ensured that the drug remains in the therapeutic range, avoiding the consequences such as over- or under-administration of the drugs. the subject of the study is to determine which of the 2 routinely used methods in rhinoplasty operations affects respiratory functions less.

Eligibility criteria:
inclusion criteria: * patients older than 18 years and younger than 60 years of age who will be operated under general anesthesia * patients in i, ii risk groups according to the american society of anesthesiologists (asa) classification exclusion criteria: * asa iii and above patients * patients for whom intensive care unit (icu) indication is prescribed * chronic obstructive pulmonary disease * having a personal or family history of malignant hyperthermia, * morbid obesity * alcohol or drug addiction * have a history of liver or kidney disease * coronary artery disease or heart failure * anemia * hemoglobinopathy * sepsis

Keywords: target controlled anesthesia oxygenation inhalation anesthesia
lactate in the gut

Conditions: Lactate; Healthy; Hyperlactatemia

Summary: lactate is formed naturally in the body in example during physical activity. however, lactate is also formed during food fermentation where certain bacterial strains form lactate. lactate can also be produced chemically. an example of this is ringer-lactate which is used for volume replacement when treating dehydrated patients. as a source of carbon-molecules, lactate is believed to be an important oxidative fuel source in all major organs and yields adenosine triphosphate (atp) production through krebs cycle, the electron transport chain in the mitochondria as well as by being a key precursor for gluconeogenesis. metformin is the first drug of choice for type 2 diabetes treatment. use of metformin often results in a small but significant weight loss in overweight users. it is known that metformin increases the lactate concentration in the gut. it is also known also know that metformin use is associated with an increase in blood concentrations of growth differentiation factor 15 (gdf-15). receptors for gdf-15 can be found in parts of the brain associated with control of appetite. in rats increases in \[gdf-15\] results in a decrease in appetite and thus weight loss. gdf-15 is thought to be involved in the normal energy homeostasis. with this study the investigators want to examine the hormonal, metabolic and mechanical effects of lactate in the gut in healthy volunteers. our hypothesis is that lactate has beneficial effects which may be though an increase in gdf-15 in the blood. volunteers will undergo two study days separated by at least 7 days and a maximum of 1 month. * on day one volunteers will drink a sodium-lactate solution (intervention). the investigators will also administrate 1500mg paracetamol to assess gastric emptying and do blood samples over 4 hours. the investigators measure \[lactate\] every 15 min. every hour the investigators will ask volunteers questions regarding hunger and thoughts of future food intake (questionnaire). after 4 hours of blood sampling the investigators will serve volunteers an all-you-can-eat meal of sandwich and measure how must they ate. * on day two volunteers will drink a sodium chloride solution. furthermore, the investigators administrate intravenous d/l sodium lactate in order to reach the same plasma \[lactate\] on day 2 as was done on day 1. the rest of day two is identical to day 1.


Eligibility criteria:
inclusion criteria: * male gender * age 18-50 years * bmi 20-30 kg/m2 * in good health with no daily use of prescription medicine based on medical history, clinical examination and blood samples. * spoken and written informed consent exclusion criteria: * chronic illness or daily use of prescription medicine . * abnormal screening blood samples as judged by the pi * does not understand or speak danish

Keywords: lactate metabolism gastric emptying gdf-15 insulin incretin hormones
epigenetic determinants of peritoneal fibrosis

Conditions: Peritoneal Fibrosis

Summary: peritoneal dialysis (pd) is a type of kidney replacement therapy for patients with chronic kidney disease where the peritoneal membrane is used to filter the blood. exposure to pd fluid results in scarring of the peritoneal membrane and increased blood vessel growth. this condition can progress even when peritoneal dialysis is stopped. therefore, the investigators hypothesize glucose in the dialysis fluid may result in dna modifications called epigenetic changes. these changes modify how genes are expressed and how cells function. the investigators want to study these epigenetic changes and the effect on peritoneal membrane scarring, blood vessel growth and peritoneal membrane function.

there is considerable evidence that epigenetic changes in effector cells underlie the progressive nature of fibrogenic diseases. the investigators have developed an ex-vivo mesothelial cell culture system based on work by aroeira and colleagues. ex vivo cell cultures were treated with the dna methyltransferase inhibitor 5-aza for 72 hours. overall, the investigators found that 11 of 14 patients' cells showed an increase in the e-cad/alpha-sma ratio with treatment to 5-aza, indicating a return to a more epithelial-like phenotype and supporting an epigenetic mechanism of progressive fibrosis. the investigators hope to identify dna methylation patterns associated with glucose exposure and peritoneal membrane solute transport in pd patients. the investigators will take the peritoneal effluent from an overnight dwell from patients within one month of initiation of dialysis. the overnight effluent is centrifuged and the pellet is washed and cells are grown in dmem medium. at confluence, cells are passaged into 2 flasks then taken for dna and rna. at 12 months, a second overnight peritoneal effluent sample will be obtained. the investigators will also gather demographic data (patient's age, diabetes, occurrence of peritonitis, cumulative pd prescription including total glucose exposure, use of icodextrin, and the results of a peritoneal equilibrium test carried out for clinical purposes between 3 and 12 months from the start of peritoneal dialysis). the investigators will use whole genome dna methylation analysis to assess epigenetic changes in mesothelial cells from incident pd patients.

Eligibility criteria:
inclusion criteria: * patients with end stage renal disease recently started on peritoneal dialysis. patients will be over the age of 18. exclusion criteria: -

Keywords: fibrosis peritoneal dialysis epigenetics peritoneal membrane injury glucose exposure
covid-19 plasma collection

Conditions: COVID-19

Summary: patients who are severely ill with covid-19 may benefit from receiving plasma infusions from donors who have recovered from the disease and are proven to no longer be infected. efforts to initiate the collection and infusion of these products to high risk patients have been initiated around the world and the fda has recently provided information about how this could be accomplished. as the jefferson blood donor center already has processes to collect, test and process blood, investigators are planning to make efforts to collect plasma for this use should it be necessary. the purpose of this study is to describe the process for identifying and collecting convalescent plasma from donors previously infected with the virus. the research portion on top of this standard blood product collection will the process of identification of subjects and processes by which blood products are processed in this special population. this protocol does not involve the administration of blood products to patients with covid-19 infection.

as described by the fda on 3/24/2020, convalescent plasma has been used for a variety of infectious diseases including ebola, sars, mers and h1n1 flu. given that there is no current medical treatment beyond supportive care for covid-19, there is a great deal of interest in using convalescent plasma for patients with covid-19. as a first step in this process, investigators are proposing to identify donors and collect plasma with antibodies against covid-19. while the intention is to use this for patients in the near future, the purpose of this study will be to see if this is feasible and a separate application will be submitted related to the treatment of patients with these products.

Eligibility criteria:
inclusion criteria: * age 18 years and older * prior diagnosis of covid-19 documented by a laboratory test approved by the fda * either: complete resolution of all covid-related symptoms for 14-28 days at the time of blood donation and negative repeated sars-cov-2 test or complete resolution of all covid-related symptoms for \> 28 days * male donors, never-pregnant female donors, or previously pregnant female donors negative for hla antibodies * meet all criteria for volunteer blood donation per jefferson blood donor center and the fda exclusion criteria: * failure to pass standard volunteer blood donor screening criteria required by the jefferson blood donor center and the fda * female donors with hla antibodies (per fda requirements for convalescent plasma donors) * inadequate venous access for phlebotomy * currently pregnant
the cstme associates with the prognosis of stage ii and iii colorectal cancer

Conditions: Colorectal Cancer

Summary: colorectal cancer (crc) is the second most commonly occurring cancer worldwide. thirty-five percent of crc patients are diagnosed at stage ii/iii, and their outcome differs even if they are in the same stage. previous study found that the microenvironmental collagen is associated with tumor progression and metastasis. whether tumor microenvironmental collagen signature is associated with colorectal cancer prognosis still remains unknown. we hypothesize that the tumor microenvironmental collagen signature of colorectal cancer is associated with prognosis.

colorectal cancer (crc) is the second most commonly occurring cancer worldwide. thirty-five percent of crc patients are diagnosed at stage ii/iii, and their outcome differs even if they are in the same stage. in the "seed and soil" theory proposed by stephen paget, tumor cells play the role of the "seed", and the tumor microenvironment (tme) is the "soil". tnm classification provides useful but uncomplete prognosis information in colorectal cancer. it lacks the assessment of the "soil" signature of tumor microenvironment. previous study found that the microenvironmental collagen is associated with tumor progression and metastasis. whether tumor microenvironmental collagen signature is associated with colorectal cancer prognosis still remains unknown. this study is a retrospective observational study performed in two centers. the main purpose of this study was to investigate whether the tumor microenvironment collagen signature (cstme) can discriminate the 5-year dfs of stage ii/iii crc patients, the secondary purpose is to compare the auc (area under the receiver operating characteristic curve) of tnm stage+cstme in predicting 5-year dfs with that of tnm stage alone. this study would introduce the tumor microenvironmental collagen signature into current colorectal cancer classification system, which would provide reference for clinical practice.

Eligibility criteria:
inclusion criteria: * pathologically diagnosed with colorectal cancer * tnm stages ii and iii (according to the 8th edition of ajcc cancer staging manual) * received radical tumor resection surgery exclusion criteria: * asa grade 4 * preoperative radiotherapy and/or chemotherapy * hereditary colorectal cancer * pregnancy
aspirin and the risk of microscopic hematuria in asymptomatic screened population

Conditions: Asymptomatic General Population; Microscopic Hematuria

Summary: aspirin can increase the risk of bleeding tendency. however, correlation between aspirin treatment and hematuria in general population is not well known. the investigators will evaluate whether daily use of aspirin increase the risk of microscopic hematuria in healthy large screened populations.


Eligibility criteria:
inclusion criteria: * age ≥ 20 years, male or female exclusion criteria: * no result of urinalysis * no record of medical history (including medication)

Keywords: aspirin screening microscopic hematuria